Quality Assurance Manager

AMN Life is a leading manufacturer and exporter of a wide range of formulations in various therapeutic segments including antibiotics, gastro, anti-inflammatories, cardiology, nephrology, CNS, and oncology. With facilities approved by EU, Health Canada, Brazil - Anvisa, and Philippines situated in Bhilad (Gujarat) and Kala Amb (Himachal Pradesh), AMN Life is equipped to handle large scale production and tech transfer projects. Headquartered in Bandra Kurla Complex, Mumbai, with offices in Singapore, UK, Australia, and Philippines, AMN Life excels in providing quality medicines at affordable prices globally. We are recognized for our strong global presence, innovative R&D, and impeccable on-time delivery record over the past 20 years.

Location:

Department:

Reports To:

Position Summary

EU GMP, USFDA, and other global regulatory requirements

Key Responsibilities

Quality Assurance (QA)

• Ensure compliance with

  EU-GMP, WHO-GMP, USFDA, MHRA, TGA, CDSCO, and other international regulatory standards

  .
• Review, approve and maintain

  SOPs, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs)

  , and master documents.
• Oversee

  deviations, change controls, CAPA, OOS/OOT

  investigations, and ensure timely closure.
• Lead

  internal audits, vendor audits, and regulatory inspections

  ; ensure readiness at all times.
• Manage

  QMS (Quality Management System)

  and ensure effectiveness across the site.
• Ensure compliance in

  cleanroom, microbiological controls, cross-contamination controls

  specific to

  ?-lactam plant operations

  .
• Oversee

  qualification & validation activities

  process validation, cleaning validation, equipment qualification, analytical method validation.
• Drive

  continuous quality improvement initiatives

  and implement best practices.

Quality Control (QC)

• Supervise QC operations including

  raw materials, in-process, finished product, microbiology, and stability studies

  .
• Ensure laboratory compliance with

  GLP

  and regulatory guidelines.
• Oversee method transfers, verification, and troubleshooting of analytical techniques.
• Approve COAs and analytical reports.

Regulatory & Compliance

• Ensure plant operations meet

  EU dossier requirements

  and customer specifications for generics.
• Prepare and review

  regulatory submissions, technical files, and CMC documentation

  .
• Act as primary contact during

  regulatory audits/inspections

  and customer audits.

Leadership & Team Management

• Lead and develop QA/QC teams with strong focus on training and skill enhancement.
• Ensure effective cross-functional collaboration between

  Production, Engineering, R&D, Regulatory, and Supply Chain

  .
• Promote a strong

  quality culture

  across the site.

Key Skills & Competencies

• In-depth knowledge of

  EU-GMP, ICH guidelines, GLP, WHO GMP, USFDA regulations

  .
• Expertise in

  formulations (OSD, injectables, suspensions, etc.)

  and

  ?-lactam manufacturing processes

  .
• Strong understanding of

  sterility assurance, microbiology, and containment strategies for ?-lactam facilities

  .
• Proficient in

  QMS tools

  (TrackWise, Veeva, or equivalent).
• Strong leadership, decision-making, and problem-solving skills.
• Excellent communication for handling

  regulatory agencies and global clients

  .

Qualifications & Experience

• Master's in

  Pharmacy / Pharmaceutical Sciences / Chemistry

  (M.Pharm / M.Sc).
• Minimum

  1015 years of experience

  in pharmaceutical QA, with at least 7

  + years in a managerial role

  .
• Hands-on experience in

  formulations, generics, and ?-lactam facilities

  .
• Proven track record of facing

  EU/MHRA/USFDA inspections

  .

Salary Range-Not disclosed

Please feel free to connect @8976869261 and share your CV at